Nuheara (ASX:NUH) says it has completed the recruitment of candidates for the clinical trial of its hearing aids being conducted by the National Acoustics Laboratory.
"This is an important milestone on the path to regulatory approval. Of further significance, more than 50% of candidates have now commenced the trial, with the remaining candidates expected to commence within the next week," said the company.
Nuheara said it has also engaged NAMSA, the world’s only 100 per cent medical device-focused contract research organisation, and a US FDA ASCA-accredited medical device biocompatibility laboratory, to conduct cytotoxicity, irritation and sensitisation testing.
The testing was conducted in accordance with ISO standards to demonstrate biocompatibility of Nuheara’s proposed hearing aid devices.
Nuheara said cytotoxicity testing was found to meet requirements, irritation testing outcomes resulted in a Primary Irritation Index of zero and sensitisation testing showed no evidence of contact sensitisation.
“We are very pleased with the excellent progress Nuheara has been making with its clinical trial and successful completion of the biocompatibility testing. These are important milestones on our planned path to FDA 510(K) submission, which remains on target for the first quarter of 2022," said Nuheara co-founder, managing director and CEO Justin Miller.
“With regulatory changes being implemented to the hearing sector in the US, we have a company defining and vast opportunity to expand into medical devices in advance of future Over the Counter hearing aid products and sales in the US. The proposed and pending FDA OTC Regulations are expected to be enacted in late 2022, and the work we are doing now to support regulatory approved hearing aids will allow Nuheara to reach and service the approximately 38 million American adults who report some level of hearing difficulty."